Medical line securement device

ABSTRACT

A securement device includes a simply-structured retention mechanism that permits a portion of a catheter hub or a similar medical article to be easily anchored to a patient, without the use of tape or needles and suturing. A unitary retainer desirably includes a base defining a locator mechanism. The locator mechanism interacts with a fitting of the medical device so as to position the medical device relative to the retainer. The locator mechanism also desirably guides the medical device fitting into contact with an adhesive member mounted on an outer surface of the retainer. In one form, the locator mechanism includes one or more posts that engage mating holes defined in the medical device fitting. In other forms, the locator mechanism includes a cradle defining an arcuate channel to receive a convex surface of the medical device, or a recess shaped to matingly receive the fitting. The retainer is attached to a flexible anchor pad that includes an adhesive bottom surface, which can be attached to the patient&#39;s skin. In use, a health care provider positions the medical device fitting on the retainer in a position established and guided by the locator mechanism, and attaches the fitting to the retainer via the adhesive member.

RELATED APPLICATIONS

This application is a continuation application of copending applicationSer. No. 11/367,200, filed on Mar. 3, 2006, which is a continuation ofSer. No. 10/744,582 filed on Dec. 23, 2003, which issued on Dec. 26,2006 as U.S. Pat. No. 7,153,291, which is a continuation of Ser. No.10/213,756 filed on Aug. 6, 2002, which issued on Feb. 10, 2004 as U.S.Pat. No. 6,689,104, which is a continuation of Ser. No. 09/845,630 filedon Apr. 30, 2001, which issued on Aug. 6, 2002 as U.S. Pat. No.6,428,516, which is a divisional application of application Ser. No.08/970,223 filed on Nov. 14, 1997, which issued on May 1, 2001 as U.S.Pat. No. 6,224,571, each of which is hereby incorporated by reference inits entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a securement device for securing amedical line or article to a patient.

2. Description of Related Art

Medical treatment of patients commonly involves the use ofpercutaneously inserted catheters to direct fluids directly into thebloodstream, a specific organ or an internal location within thepatient, or to monitor vital functions of the patient. For instance,short, peripherally-inserted, intra-arteriovenous catheters are commonlyused to direct fluids and/or medications directly into the bloodstreamof the patient.

The fluid (e.g., parenteral liquid, medication, etc.) typically drainsfrom a container positioned above the patient to feed under gravity oris delivered via an infusion pump. The fluid flows through tubing andthence into the indwelling catheter. The catheter and the fluid tubingare commonly removably attached to each other by a conventionalluer-lock connector.

In common practice, a health care provider uses adhesive, foam orsurgical tape to maintain the catheter in place on the skin of thepatient. The health care provider wraps a thin piece of tape around thehub of the catheter and then forms a “chevron” with the tape, placingthe ends next to the sides of the indwelling catheter. The health careprovider then places one piece of across and over the catheter hub,forms a loop in the tubing, places another piece of tape across thetubing loop, and places yet an additional piece of tape over thecatheter hub and the tubing section that has been looped around andextends next to the indwelling catheter. Subsequently, the health careprovider typically covers the insertion site and the indwelling catheterwith a transparent dressing.

The entire taping and dressing procedure takes several minutes of thehealth care provider's valuable time. In addition, the catheterizationprocess often requires relatively frequent disconnection between thecatheter and the fluid supply tube, as well as dressing changes. Forinstance, intravenous catheterization is frequently maintained forseveral days, depending upon the condition of the patient. The tubing isgenerally replaced every 48 to 72 hours in order to maintain thesterility of the fluid and the free-flow of the fluid through thetubing. A health care provider thus must frequently change the tubingand re-tape the connection. The health care provider also mustfrequently clean the insertion site about the indwelling catheter andchange the dressings.

The health care provider thus uses a great deal of valuable timeapplying, removing and reapplying tape. The frequent application andremoval of the tape also commonly excoriates the patient's skin aboutthe insertion site.

In addition, the traditional method of intravenous cathetersecurement—surgical tape and transparent dressings alone—have not alwaysprevented catheter migration and/or dislodgment. Taped intravenouscatheters are also easily pulled out during a “routine” dressing change,especially by inexperienced health care providers. And if the cathetermigrates too far or dislodgment occurs, the health care provider mustreplace the catheter, thus exacerbating the time and expense required tomaintain the intravenous feed.

Prior securement methods also have not served the patient well. Surgicaltape or foam strips are uncomfortable. Many patients also do not restcomfortably and worry about catheter dislodgment when they move, whenonly tape and a dressing secure the catheter in place.

Several additional drawbacks result from the use of tape to stabilizethe catheter. One is contamination. Health care providers often tear offsmall strips of tape and place then on the hand rail on the patient'sbed. Clostridium and other bacteria, however, commonly exist on thesesurfaces and can be transferred to the patient's skin in the proximityof the insertion site.

In addition, tape securement requires the nurse to handle the tape whilewearing protective latex gloves. Tearing adhesive tape tends to producemicroscopic and/or visible holes in the gloves and thus destroys glovebarrier protection.

A number of catheterization systems have been developed to improved thestability of the catheter and to obviate the need for frequentapplication and removal of surgical tape. Prior devices, however, havegenerally held the connector on the IV tubing securely against thepatient, rather than the catheter fitting itself.

SUMMARY OF THE INVENTION

The present invention involves the recognition that where (i) thecatheter securement device secures the connector on the tubing, ratherthan the catheter fitting, and (ii) the interconnection between the tubeconnector and the catheter fitting occurs across a bendable anatomicjoint (e.g., the patient's wrist), a possibility exists for relativemovement to occur between the indwelling catheter and the correspondingvessel (e.g., vein). As a result of such movement, the catheter undersome circumstances may become dislodged, requiring re-catheterization ofthe IV catheter, re-securement of the catheter, and redressing of theinsertion site. Again, such catheter migration and/or dislodgment leadsto increased time and expense associated with maintaining an intravenousfeed.

A need therefore exists for a simply-structured securement device thatretains a medical line in a fixed position on a patient's body, butreleases the medical line for dressing changes or other maintenance,even where the catheter-tubing connection spans an anatomic joint. Anadditional need exists for a securement device that incorporates aversatile medical line retaining mechanism, i.e. a device that can beused to attach one of a variety of medical line fittings to an insertionsite on a patient's body.

One aspect of the present invention involves a securement device systemfor securing a medical line to a body of a patient. The securementdevice comprises a mounting surface that is at least partially coveredby an adhesive layer for attaching the securement device to thepatient's body. A receiving surface is located distal of the mountingsurface. An adhesive member at least partially covers the receivingsurface and is positioned to contact at least a portion of the medicalline secured by the securement device. A locator mechanism interactswith the medical line and positions the medical line portion on thereceiving surface relative to the adhesive member.

A preferred method of manufacturing a medical line securement deviceinvolves affixing a sheet of a backing material to a sheet ofadhesive-backed foam material, then cutting a first pattern through thesheet of foam material without cutting through the sheet of backingmaterial, the first pattern at least partially defining an anchor pad. Asecond pattern is then cut through both the sheet of foam material andthe sheet of backing material, the second pattern defining on thebacking material a release layer for exposing the adhesive backing ofthe anchor pad prior to attaching the securement device to the patient'sbody. A retainer is formed (e.g., molded, or extracted) to include alocator mechanism that is adapted to interact with a portion of themedical line and to thereby guide the medical line into a positionrelative to the retainer. The retainer is attached to a surface of theanchor pad, and a patch of an adhesive material is applied to a surfaceof the retainer. A release layer is affixed over the adhesive patch, butis removable to expose the adhesive patch during use.

A preferred method of securing a medical line to a patient involvesproviding a securement device having a first adhesive member on oneside, a second adhesive member on an opposite side, and a locatormechanism. The locator mechanism is engaged with a portion of themedical device so as to position the medical device portion generallyover the first adhesive member. The medical device thence is engagedwith the first adhesive member to secure the medical device to thesecurement device. The second adhesive member is placed on the patient'sbody to secure the securement device, and thus the retained portion ofthe medical line, to the patient.

Further aspects, features, and advantages of the present invention willbecome apparent from the detailed descriptions of the preferredembodiments that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The illustrated embodiments of the securement device are intended toillustrate, and not to limit the invention, and contain the followingfigures:

FIG. 1 is a perspective view of a medical line securement deviceconfigured in accordance with a preferred embodiment of the presentinvention, and illustrates an exemplary catheter hub positioned abovethe securement device;

FIG. 2 is a top plan view of the securement device of FIG. 1;

FIG. 3 is a perspective view of a securement device configured inaccordance with another preferred embodiment of the present invention;

FIG. 4 is a perspective view of a securement device configured inaccordance with an additional preferred embodiment of the presentinvention;

FIG. 5 is a perspective view of a securement device configured inaccordance with another preferred embodiment of the present invention,and illustrates an exemplary catheter hub in a retained position;

FIG. 6 is a top plan view of the securement device of FIG. 5 in an openposition without the retained catheter hub;

FIG. 7 is a cross-sectional view of a portion of the securement deviceof FIG. 6 taken along line 7-7, and illustrates with the securementdevice in an open position with the catheter hub positioned above thesecurement device;

FIG. 8 is a cross-sectional view of securement device of FIG. 5 takenalong line 8-8 and illustrates the securement device in a closedposition receiving the catheter hub;

FIG. 9 is a perspective view of a medical line securement deviceconfigured in accordance with an additional preferred embodiment of thepresent invention and illustrates a catheter fitting positioned abovethe securement device;

FIG. 10 is a cross-sectional view of the securement device of FIG. 9,taken along the line 10-10;

FIG. 11 is a cross-sectional view of the securement device according toFIG. 10, but with tangs shown in an open position;

FIG. 12 is a cross-sectional view of the securement according to FIG.10, but with a fitting of the medical line in the latched position;

FIG. 13 is a partially exploded perspective view of a securement deviceconfigured in accordance with another preferred embodiment of thepresent invention;

FIG. 14 is a perspective view of the securement device of FIG. 13 in anassembled form and illustrates a catheter fitting positioned above thesecurement device;

FIG. 15 is a partially exploded perspective view of a securement deviceconfigured in accordance with an additional preferred embodiment of thepresent invention; and

FIG. 16 is a perspective view of the securement device of FIG. 15 in anassembled form and illustrates a catheter fitting positioned above thesecurement device.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

The present embodiments of the medical line securement device aredisclosed in the context of an exemplary intravenous (IV) catheter. Theprinciples of the present invention, however, are not limited to IVcatheters. Instead, it will be understood by one of skill in this art,in view of the present disclosure, that the securement devices andretainers disclosed herein also can be successfully utilized inconnection with other types of medical lines, including tubes for fluidcommunication and electrical wires. For example, but without limitation,the retainers disclosed herein can be adapted to retain CVCs, PICCs,Foley catheters, and hemodialysis catheters, surgical drainage tubes,feeding tubes, chest tubes, nasogastric tubes, scopes, as well as withelectrical wires or cables connected to external or implanted electronicdevices or sensors. One skilled in the art may also find additionalapplications for the devices and devices disclosed herein. Thus, theillustrations and descriptions of securement devices disclosed herein inconnection with a catheter are merely exemplary of one possibleapplication of the device.

Each of the embodiments described herein employ the same basic conceptscharacteristic of the improved securement device, namely attachment of amedical line or article to a patient by use of an adhesive member thatadheres to the medical line or article. The securement devices also allinclude interacting structure that operates between the securementdevices and a portion of the medical line or article (e.g., a fittingwhich either is releasably attached to the medical line or article or isintegrally formed with the medical line or article). The interactingstructure between the retainer and the portion of the medical line orarticle generally inhibits relative movement between the medical lineand the securement devices in at least one degree of freedom. Thisinteraction also properly locates the portion of the medical line orarticle on the securement device and guides the medical line or articleportion into contact with the adhesive member.

To assist in the description of the components of the securement devicesand retainers disclosed herein, the following coordinate terms are used.A longitudinal axis is generally parallel to a section of the medicalline to be retained by the securement device, generally in the plane ofa base or pad of the securement device (discussed below). A lateral axisis generally perpendicular to the longitudinal axis within the plane ofthe base. A transverse axis extends transverse to both the longitudinaland lateral axes. FIG. 1 illustrates this coordinate system to the sideof the securement device. The illustrated coordinate system applies tothe perspective views of each of the preferred embodiments illustratedherein. In addition, as used herein, the “longitudinal direction” refersto a direction substantially parallel to the longitudinal axis. “Thelateral direction” refers to a direction substantially parallel to thelateral axis. And, “the transverse direction” refer to a directionsubstantially parallel to the transverse axis. These coordinates areused to describe structures and movement of the securement device ofeach embodiment. A detailed description of each embodiment, and itsassociated method of use, now follows.

FIGS. 1-2 illustrate an securement device 8 constructed in accordancewith a preferred embodiment of the present invention. The securementdevice 8 is configured to retain a catheter 10, either directly or byway of a fitting 12, as in the illustrated embodiment. Thus, thefollowing description first provides a brief description of the catheterfitting 12 before describing the securement device 8 in order to aid thereader's understanding of this embodiment.

FIG. 1 illustrates an exemplary short, peripheral IV catheter, such asthe type available from B. Braun Mesungen AG. The fitting 12 of thiscatheter 10 includes a conical receptacle 14 in fluid communication withthe catheter 10 and having a threaded rim 16 for releasably attaching toa fluid tubing (not shown) to place the tubing in fluid communicationwith the catheter 10. The fitting 12 also includes a pair of lateralwings 18 that extend roughly perpendicularly from a lower portion of thefitting 12. Each wing 18 includes a through-hole 20. A medial surface 22of the fitting 12, including portions of the lateral wings 18, has agenerally flat, cruciform-shaped foot print.

The securement device 8 receives and directly anchors the catheterfitting 12 to the patient, rather than holding a point in the medicalline upstream of the catheter 10 (e.g., the connector between thecatheter and the fluid supply tube). For this purpose, the securementdevice 8 includes an adhesive member 24 against which the medial surface22 of the catheter fitting 12 is placed. Desirably, the shape of theadhesive member 24 generally corresponds to the shape of catheterfitting's foot print, and the adhesive member 24 is coextensive with orslightly smaller than the size of the fitting's foot print. Thus, in theillustrated embodiment, the adhesive member 24 has generally a cruciformshape.

The adhesive member 24 desirably has a sufficient thickness andtackiness to either secure and/or encapsulate (at least to some degree)the catheter fitting 12 in order to inhibit relative movement betweenthe securement device 8 and the catheter fitting 12. The adhesive member24 can be applied to the securement device 8 in any of a variety ofconventional ways, such as by transfer technology (e.g., thin filmtransfer tape) or by sputtering. For instance, in the illustratedembodiment, the adhesive member 24 is formed of a transfer adhesiveavailable from Minnesota Mining and Manufacturing Company (3M), ofMinneapolis, Minn., as Part No. 950.

As seen in FIG. 1, a release layer 26 can initially cover the adhesivelayer 24 before use. In the alternative, the packaging (not shown) forthe securement device 8 can function as the release layer 24. In eithercase, a suitable material covers the adhesive member 24 prior to thesecurement device's application on a patient. Such suitable materialincludes, for example, but without limitation, a polycoated, siliconizedpaper.

The securement device 8 also includes a locator mechanism to properlyposition the catheter fitting 12 on the adhesive member 24. Any of awide variety of locator mechanism can be used for this purpose, asillustrated by the various embodiments described below. For instance, asseen in FIGS. 1 and 2, the securement device 8 desirably includes atleast one post 28 which cooperates with one of the holes 20 in thecatheter fitting wings 20.

In the illustrated embodiment, the securement device 8 desirablyincludes a pair of posts 28; however, the securement device 8 can alsoinclude additional posts to suit a specific application. For example,where the securement device is designed to secure a relatively largefitting, the securement device can include four posts arranged at thecorners of a rectangle, for greater stability. As another example, threeposts can be used to firmly anchor a Y-site fitting.

The posts 28 can have any of a variety of lengths and diameters, as wellhave a variety of distances between them, depending upon the particularapplication and the particular catheter fitting with which they are tointeract. For applications with known catheters, each post 28 desirablyhas a length of about 4 mm to 20 mm, and more particularly a length ofabout 6 mm; however, longer or shorter lengths also are possible. Thepost diameter desirably is slightly smaller than the corresponding hole20 of the catheter fitting 12 but is sufficiently large to inhibitsignificant bending of the post 28 under normal forces experienced onthe medical line. The posts 28 desirably are of comprise a polymerplastic material, with a diameter between 0.5 mm and 3 mm, and morepreferably with a diameter about 1.7 mm.

The posts 28 are laterally spaced at least wide enough to accommodatethe medical line or article to be anchored, and, in the illustratedembodiment, desirably correspond to the spacing between the holes 20 inthe catheter fitting wings 18. For application with most knowncatheters, the posts 28 are spaced apart by a distance between about 5mm and about 40 mm, and more particularly by a distance equal to about15 mm.

In the illustrated embodiment, as seen in FIGS. 1 and 2, the securementdevice 8 includes a retainer, generally designated by reference numeral30, mounted on a flexible anchor pad 32. The retainer 30 includes a base34 which supports the locator mechanism (e.g., the posts 28) and theadhesive member 24 of the retainer 30. The base 34 desirably has aplanar shape that defined in part a receiving surface (generallydesigned by reference numeral 36) for the catheter fitting 12. The posts28 extend generally normal to the receiving surface 36 of the base 34with the adhesive member 24 located on the receiving surface 36 andbetween the posts 28.

The base 34 and the posts 28 of the retainer 30 desirably are integrallyformed as a unitary piece. This can be accomplished in any of a varietyof ways well known to one of skill in the art. For instance, the entireretainer 30 can be injection molded, in order to reduce fabricationcosts. Suitable plastics from which the posts 28 and base 34 can be madeinclude, for example, but without limitation, polypropylene,polyethylene, and the like. In particular, acceptable materials includeTenite® 811 low density polyethylene (LDPE) available commercially fromEastman Chemical Company, of Kingsport, Tenn., and polypropylene(#P6M5B-015) and polypropylene copolymer (#P6M5Z-036), both availablecommercially from Huntsman Chemical, Salt Lake City, Utah.

As mentioned above, the adhesive member 24 can be applied to the base 34in a variety of ways, including, but without limitation, by transfertape or sputtering. If applied by transfer tape, the application can bedone as part of a converter process, described below.

The base 34 of the retainer 30 is attached to the anchor pad 32. Thebase 34 desirably is secured to the anchor pad 32 by a solvent bondadhesive, such as cyanoacrylate or other bonding material. One suchadhesive is available commercially as Part No. 4693 from 3M.

The anchor pad 32 comprises a flexible structural layer for securing theretainer 30 to a patient's skin. The pad 32 desirably comprises alaminate structure with an upper foam layer (e.g., closed-cellpolyethylene foam), and a bottom adhesive layer. The adhesive preferablyis a medical-grade adhesive and can be either diaphoretic ornondiaphoretic, depending upon the particular application. The anchorpad 32 desirably is formed from a polyethylene foam tape ( 1/32 to ⅛inch thick) with an acrylic adhesive, 40 to 120 grams/square meterthick. Such foam with an adhesive layer is available commercially fromNew Dimensions in Medicine of Columbus, Ohio.

An upper surface of the foam layer of the anchor pad 32 is roughened bycorona-treating the foam with a low electric charge. The roughened orporous upper surface of the anchor pad 32 improves the quality of theadhesive joint formed by the cyanoacrylate (or by another type ofadhesive or bonding material) between the base 34 and the anchor pad 32.In the alternative, the flexible anchor pad 32 can comprise amedical-grade adhesive bottom layer, an inner foam layer and an upperpaper or other woven or non-woven cloth layer.

A removable paper or plastic backing or liner 38 desirably covers thebottom adhesive surface before use. This release layer 38 preferablyresists tearing and is divided into a plurality of pieces to easeattachment of the pad to a patient's skin. In the illustratedembodiment, the backing is a polycoated, siliconized paper.

The backing desirably is split along a center line CL of the flexibleanchor pad 32 in order to expose only half of the adhesive bottomsurface at one time. The backing 38 also advantageously extends beyondat least one edge of the anchor pad 32, as illustrated, to facilitateremoval of the backing 38 from the adhesive layer.

Although not illustrated, the retainer 30 and/or the anchor pad 32 caninclude suture holes in addition to the adhesive layer to further securethe anchor pad to the patient's skin.

In the illustrated embodiment, the anchor pad 32 also desirably includesa pair of opposing concave sections that narrows the center of theanchor pad 32 proximate to the retainer base 34. As a result, theperipheral ends of the anchor pad 32 have more contact area to providegreater stability and adhesion to a patient's skin, while allowing theretainer 30, which is located at center section of the anchor pad 32, tobe placed adjacent to a catheter insertion site.

The anchor pad 32 and release layer 38 (i.e., backing) are formed usinga converter process. A sheet of backing material is initially appliedonto the adhesive surface of the foam material. (The foam is purchasedwith a backing; however, a new backing desirably is applied whichincludes printed indicia that identifies the manufacturer of thesecurement device 8.)

A first pattern is cut multiple times in the sheet of adhesive-backedfoam material through the conversion process. This may be done using adie-cut technique which “kiss-cuts” only the foam material in the firstpatters without cutting the backing material. The cut first patterndesirably corresponds to at least a portion of the anchor pad 32. Thatis, the first pattern, which is cut into the foam material, at leastpartially defines the shape of the anchor pad 32.

A second pattern is then cut multiple times into the sheet ofadhesive-backed material (i.e., the foam material) and the backingmaterial. The second pattern defines the balance of the anchor padshape, as well as the exposed portion of the release layer 38. Thisprocess likewise can be done by die-cutting.

The release liner 38 also is cut into its two halves without cutting thefoam layer. This process can be done either before or after the secondpattern is cut and also can be accomplished by a die cut. Multipleanchor pads thus are produced from a single sheet thefoam/adhesive/backing laminate structure through this conversionprocess.

In use, the health care provider removes the securement device from itsprotective, sterile packaging (not shown) and peals off the releaselayer 26 from the adhesive member 24 if provided separate from thepackaging. Otherwise, the adhesive member 24 emerges uncovered from thepackaging. The health care provider then aligns the posts 28 with sutureholes 20 in the catheter fitting wings 18 and inserts the posts 28 intothe holes 20. The interaction between the holes 20 and the posts 28properly positions the catheter fitting 12 on the retainer 30. Thehealth care provider then moves the catheter fitting 12 into contactwith the adhesive member 24 and presses the catheter fitting 12 againstthe retainer 30 to ensure good contact between the adhesive member 24and the medial surface 22 of the catheter fitting 12. As a result of thecorresponding shapes of the adhesive member 24 and medial surface 22 ofthe catheter fitting 12, the medial surface 22 completely covers theadhesive member 24, thereby inhibiting exposure of the adhesive member24. Because exposed adhesive can become sites for bacterial growth,minimizing such exposure substantially reduces the risk of a insertionsite infection.

The health care provider desirably secures the anchor pad 32 to thepatient after attaching the catheter fitting 12 to the retainer 30. Thisstep can be done before catheter fitting attachment, but it requiresplacing the anchor pad 32 on the patient in a position preciselyaligning the retainer 30 beneath the catheter fitting 12. Regardless ofthe order of these acts, the health care provider secures the anchor padto the patient by first removing one half of the release layer andpressing the anchor pad against the patient's skin, adhesive side facedown. The health care provider then removes the other half of therelease layer and smoothes the anchor pad 32 against the patient. Thesecurement device 8 in this position securely anchors the catheterfitting 12 to the patient.

FIG. 3 illustrates a medical line securement device 8 a in accordancewith another embodiment of the present invention. The above descriptionin relation to FIGS. 1 and 2 applies equally to the embodiment of FIG.3, unless otherwise indicated. In addition, like reference numerals areused to indicate like features among the embodiments, with the letter“a” added as a suffix to refer to features of the present embodiment.

The securement device 8 a comprises a retainer 30 a. The retainer 30 ais similar to the retainer illustrated in FIGS. 1-2, except that thebase 34 a of the retainer 30 a comprises a raised pedestal 40 extendingupwardly from the base 34 a and defining a portion of the receivingsurface 36 a. The raised pedestal 40, the base 34 a and the posts 28 adesirably are all integrally formed in an unitary retainer 30 a.

The adhesive member 24 a is formed on an upper surface of the raisedpedestal 40, and a release layer 26 a covers the adhesive member 24 a.Alternatively, the packaging (not shown) functions as the release layer,as described above.

The raised pedestal 40 of the retainer 30 a preferably has a planarupper surface on which the adhesive layer 24 a is located. Desirably,the plane generally defined by the upper surface of the raised pedestal40 desirably forms an acute angle with the planar surface of the base 34a. The angled upper surface imparts an angular orientation to thecatheter fitting relative to the patient's skin. The resulting incidentangle desirably ranges between about 0° and 15°, depending upon theapplication of the catheter securement device 8, as known in the art.

An anchor pad 32 a supports the retainer 30 a. A release layer (notshown) covers an adhesive underside of the anchor pad 32 a prior toapplication of the anchor pad 32 a to the patient, as described above.

FIG. 4 illustrates a medical line securement device 8 b in accordancewith another embodiment of the present invention. The above descriptionwith respect to the embodiment of FIGS. 1 and 2 applies equally to theembodiment of FIG. 4, unless otherwise indicated. In addition, likereference numerals are used to indicate like features among theembodiments, with the letter “b” added as a suffix to refer to featuresof the present embodiment of FIG. 4.

The retainer 30 b is similar to the retainer of FIG. 1, except that theretainer 30 b includes a cradle 42 extending upwardly from the base 34 bof the retainer 30 b. The adhesive member 24 b desirably lies within thecradle 42 and covers at least a portion of the receiving surface 38 bdefined by the cradle 42. A release layer 26 b can initially cover theadhesive member 24 b, or the packaging can serve this function, asdescribed above.

In addition, a foam layer 46 desirably is interposed between the surfaceof the channel 44 and the adhesive layer 24 b. The foam layer 46provides for good contact between the adhesive layer 24 b and thesurface of the catheter fitting, despite the presence of protuberanceson the surface of the catheter fitting. That is, the foam layer 46allows the adhesive layer 24 b to follow the contours of the juxtaposedcatheter fitting surface.

The cradle 42 preferably has a concave, arcuate upper surface that formsa channel 44 and functions as the receiving surface of the retainer 30b. Desirably, the surface of the channel 44 conforms substantially to aportion of a surface of a cone, thereby allowing the channel to mateeasily with a conically-shaped catheter fitting, such as the fittingillustrated in FIG. 1. Because the arcuate surface of the channel 44 canbe used to guide a catheter fitting into a desired position relative tothe retainer 30 b and onto the adhesive layer 24 b, posts 28 b (shown inphantom lines in FIG. 4) are optional in the present embodiment. Suchposts 28 b, in conjunction with corresponding suture holes, such as theholes 20 in the catheter fitting wings (see FIG. 1), may make it easierfor a health care provider to position a catheter fitting relative tothe retainer 10 c and therefore may be used if desired. In thisembodiment, both the shape of the channel 44 and the posts 28 b, ifincluded, function as the locator mechanism of the retainer 30 b.

An anchor pad 32 b supports the retainer 30 b. A release layer (notshown) desirably covers an adhesive underside of the anchor pad 32 bprior to application of the anchor pad 32 b to the patient, as describedabove.

FIGS. 5-8 illustrate a medical line securement device 8 c in accordancewith another embodiment of the present invention. The above descriptionwith respect to the embodiment of FIGS. 1 and 2 applies equally to theembodiment of FIGS. 5-8, unless otherwise indicated. Like referencenumerals are used to indicate like features among the embodiments, withthe suffix “c” added to refer to features of the present embodiment.

The retainer 30 c and anchor pad 32 c of securement device 8 c aresimilar to those illustrated in FIG. 1, except that the locatormechanism takes the form of a cradle 48 with movable walls 50. Theadhesive member 24 c desirably lies within the cradle 48 and covers atleast a portion of the receiving surface as defined by the cradle 48. Arelease layer (not shown) can initially cover the adhesive member 24 cor the packaging can serve this function, as described above.

As best understood from FIGS. 6, 7 and 8, the cradle includes a channel52 of tapering width, which includes an arcuate surface that functionsas the receiving surface of the retainer 30 c. Desirably, the shape ofthe channel 52 conforms substantially to a portion of a cone (i.e., hasa frusto-conical shape), thereby allowing the channel 52 to mate easilywith a conically-shaped section of the catheter fitting 12 c.

The channel 52 is defined in part by the opposing wall sections 50. Eachwall section 50 has an arcuate shape of a radius of curvature thatgenerally matches the catheter fitting 12 c. Each wall section 50 alsoextends through an arc length of generally greater than 90□ such thattogether the wall sections 50 surround at least 180□ of theconical-shaped catheter fitting 12 c.

A flexible coupling, generally identified by reference numeral 54,interconnects the wall sections 50 of the cradle 48 and supports thecradle 48 about retainer base 34 c. In the illustrated embodiment, theflexible coupling 54 is integrally formed with the base 34 c, as well aswith the wall sections 50. The flexible coupling 54 includes a pair ofgenerally parallel rails 56. Each rail 56 includes a necked-down sectionformed between the base 34 c and the corresponding wall section 50. Thisneck section is flexible and permits the corresponding wall section 50to move relative to the base 34 c.

The wall sections 50 thus are movable relative to each other and to thebase 34 c. Desirably, the flexible coupling 54 normally holds the wallsections 50 in an open position, as illustrated in FIG. 7, in which theupper ends (distal of the base 34 c) of the wall sections 50 are spacedapart. The flexible coupling 54 permits the wall sections 50 to movetoward each other into a closed position, as seen in FIG. 8. In thisposition, the upper ends of the wall sections 50 are spaced closelytogether, and the channel's shape and size generally matches that of theretained section of the catheter fitting 12 c. The cradle 48 in theclosed position thus extends more than 180□ around the circumference ofthe catheter fitting 12 c.

The flexible coupling 54 also includes an actuator mechanism to move thewall sections into the closed position once the channel 52 has receivedthe catheter fitting 12 c. In the illustrated embodiment, the actuatormechanism includes a pair of lugs 58 that extend from the lower ends ofthe wall sections 50 between the rails 56. Each lug 58 has an innersurface (i.e., a surface within the channel 52) with an arcuate shapethat generally matches that of the corresponding wall section 50. Thelugs 50 are also oriented and sized to have a slight upwardlyorientation when the cradle 48 is in the open position, as seen in FIG.7. But when the catheter fitting 12 c is pressed into the channel 52,the lugs 58 move downward. The downward movement of the lugs 58 causesthe attached wall section 50 to pivot about the corresponding rail 56with the neck section of the rail 56 flexing, as seen in FIG. 8.

A foam layer 60 is placed within the channel 52 and lines at least aportion of the channel's surface. The foam layer 60 not only compensatesfor irregularities in the catheter fittings surface, but it also acts asa substrate for the adhesive member 24 c. In the illustrated embodiment,the foam layer 60 and the adhesive layer 24 c line the entire innersurface of the cradle's channel 52.

In use, the conical section of the catheter fitting 12 c is insertedinto the cradle 48 while the flexible coupling 54 holds the cradle walls50 in the open position. The opposing walls 50 of the cradle 48 thenclose about the fitting 12 c, placing the adhesive member 24 c incontact with the outer surface of the fitting 12 c thereby securing thefitting 12 c to the retainer 30 c.

FIGS. 9-12 illustrate a medical line securement device 8 d in accordancewith another embodiment of the present invention. The above descriptionwith respect to the embodiment of FIGS. 1 and 2 applies equally to theembodiment of FIGS. 9-12, unless otherwise indicated like referencenumerals are used to indicate like features among the embodiments, withthe letter “d” added to refer to features of the present embodiment.

The retainer 30 d comprises a clamping mechanism formed by a pair ofopposing latches 62. The latches 62 are spaced apart from each other onthe base 34 d, and the adhesive member 24 d is located between thelatches 62. In the illustrated embodiment, the latches 62 and base 34 dare integrally formed together in the form of a unitary retainer 30 d,such as, for example, but without limitation, by molding, extracting, orthermal forming, and the adhesive member 24 is applied in any of theabove-described manners.

Each latch 62 includes a tang 64, which projects toward the other latch62, and a generally upright support 66, which suspends the tang 64 abovethe base 34 d. An actuator or lug 68 is attached to the support 66 at apoint above the base 34 d. The actuator 68 desirably includes aroughened upper surface and/or friction ridges in order to enhancefrictional contact between the actuator 68 and the user's finger tips.In the illustrated embodiment, each actuator 68 lies to the outerlateral side of the corresponding tang 64 at the top of the uprightsupport 66. In this position, movement of the actuator 68 toward thebase 34 d causes the support 66 to flex and moves the tang 64 away fromthe other latch 66, as seen in FIG. 11.

In the illustrated embodiment, the upright supports 66 have elongatedshapes and are arranged on the base 34 d generally parallel to eachother. The supports 66, together with the base 34 d, define a generallyrectangular channel 70. The opposing tangs 64 of the latches 62 reducethe size of the channel's upper opening. The floor of the channel 70defines at least a portion of the receiving surface 36 d of the retainer30 d.

The channel 70 is sized to receive the catheter fitting wings 18 d, andthe latches 62 are arranged on the base 34 d to snap over the wings 34 dto latch the catheter fitting 12 d within the channel 70.

In operation, both actuators 68 are depressed by finger pressure, asschematically illustrated in FIG. 11, causing the supports 66 to bendlaterally outward. This outward bending of the supports 66 allowslateral wings 18 d of the catheter fitting to be placed between thesupports 66, thereby bringing a medial surface 22 d of the fitting 12 din contact with the adhesive pad 24 d. After insertion of the catheterfitting wings 18 d into the channel 70, the finger pressure on theactuators 68 can be released, thereby allowing the tangs 64 to partiallycover an upper surface of the catheter fitting wings 18. Accordingly,the fitting 12 d is secured to the retainer 30 d in two ways: first, bythe adhesive force of the adhesive member 24 d to the medial surface 22d of the fitting 12 d; and second, by the placement of tangs 64 over topof the fitting wings 18 d.

FIGS. 13-14 illustrate a medical line securement device 8 e inaccordance with another embodiment of the present invention. The abovedescription with respect to the embodiment illustrated in FIGS. 1 and 2applies equally to the embodiment of FIGS. 13-14, unless otherwiseindicated. Like reference numerals are used to indicate like featuresamong the embodiments, with the suffix “e” added to refer to features ofthe present embodiment.

The retainer 30 e comprises plate with a recess or well formed therein.The plate can be formed of any of a wide variety of materials, includinga plastic polymer. In the illustrated embodiment, however, the retainer30 e comprises a foam pad defining an aperture 72 therethrough. As shownin FIG. 14, the aperture 72 has a shape corresponding to the shape of acatheter fitting's foot print, and thereby locates the catheter fitting12 e relative to the retainer 30 e.

An adhesive member 24 e is applied to an anchor pad 32 e generally atthe center of the pad 32 e. The size and shape of the adhesive member 24e desirably matches the size and shape of the foam pad 30 e. Theadhesive member 24 e desirably has a uniform thickness and covers theentire area within its perimeter. As a result, a portion of the adhesivemember 24 e is exposed through the opening. A release layer (not shown)or the product packaging desirably covers the adhesive ember 24 e priorto use, as described above.

The foam pad retainer 30 e and its aperture 72 can be formed during aconversion process during a die cut procedure. The application of theadhesive member 24 e and the attachment of the foam pad retainer 30 e tothe adhesive member 24 e can also occur as steps during the conversionprocess.

Although not illustrated, the well or recess need not extend entirelythrough the foam pad, but rather can take the form of an embossment. Inthis form, the adhesive member can be applied to the floor of the recessso as to be accessible from a side of the anchor pad opposite of thepatient's skin. Again, at least a portion of the recess is configured tocorrespond to the secured portion of the catheter fitting wings in shapeand size.

In operation, the catheter fitting 12 e is moved toward and placed intothe recess 72 so as to position a medial surface 22 e of the fitting 12e relative to the adhesive member 24 e. The medial surface 22 e isthence pressed into contact with the adhesive member 24 e to secure thecatheter fitting 12 e to the securement device 8 e. The anchor pad 32 eis secured to the patient's skin in the manner described above.

FIGS. 15-16 illustrate a medical line securement device 8 f inaccordance with another embodiment of the present invention. Thedescription of the embodiment of FIGS. 1 and 2 applies equally to theembodiment of FIGS. 15-16, unless otherwise indicated. Like referencenumerals are used to indicate like features among the embodiments, withthe suffix “f” added to refer to features of the present embodiment.

This embodiment is also similar to that illustrated in FIGS. 13-14,except that the need for a retainer. The retainer illustrated in FIG. 13is eliminated in the present embodiment, and a recess or well 74 isdefined in the anchor pad 32 f itself. In the illustrated embodiment,the recess 74 extends entirely through the anchor pad 32 f; however, therecess can take the form of an indentation in the pad 32 f. In eithercase, the recess 74 desirably has a similar shape and size to at least aportion of the catheter fitting 12 f. And preferably, the recess 74generally matches the foot print of the catheter fitting 12 f in shapeand size.

The adhesive member 24 f is located on the bottom of the recess. In theillustrated embodiment, though, where the recess extends through the pad32 f, a substrate 76 supports the adhesive member 24 f at this location.The adhesive member 76 desirably covers the entire substrate 76 andsecures it to a side of the anchor pad on which the adhesive layer isformed. Thus, the substrate can include adhesive layers on both of itssides.

The use of the present securement device 8 f is similar to thatassociated with the securement device illustrated in FIGS. 13 and 14.The catheter fitting 12 f is moved toward and placed into the recess 74so as to position a medial surface 22 f of the fitting 12 f relative tothe adhesive member 24 f. The medial surface 22 f is thence pressed intocontact with the adhesive member 24 f to secure the catheter fitting 12f to the securement device 8 f. The anchor pad 32 f is secured to thepatient's skin in the manner described above.

As common to all of the embodiments described above, the securementdevice includes adhesive layers on two sides. One side adheres to thepatient, while the other side adheres to the medical line or article. Inorder to properly position the medical line on the securement device andto enhance the speed and ease of applying the securement device, each ofthe above-described securement devices also include a locator mechanism.Proper positioning promotes good contact between the adhesive member andthe medical line or article to enhance securement, as well as ensuresthat the medical line or article completely covers the adhesive member.As a result, the adhesive tends not to become a sites for bacterialgrowth. The locator mechanism also allows the health care provider toproperly position the medical line or article on the securement devicewith minimum time and effort.

For use with catheter type devices, each of the securement devicesdescribed above secures the catheter fitting to the patient, rather thansecures the connector on the tubing to the patient as done by priordevices. The catheter thus does not move with movement of an anatomicjoint when an interconnection between the catheter and the tubing spansacross the joint.

Also as common to each of the above-described embodiments, thesecurement device provides a sterile, stable, efficient way to anchor amedical line or article to a patient. The securement device is quicklyand easily applied to the medical line or article by using the locatormechanism, and is equally quickly and easily applied to the patient'sskin. During the application process, the health care provider need notcontact the adhesive layers with his or her gloves. Use of thesecurement device thus does not degrade glove protective. Once secured,the securement device stabilizes the catheter and substantially preventscatheter movement and migration.

Although not illustrated, each of the above-described securement devicescan include one or more tube clips, especially for use with intravenouscatheters. An exemplary tube clip is described and illustrated in U.S.Pat. No. 5,578,013, issued in the name of Steven F. Bierman, on Nov. 26,1996, and to the assignee hereof, which is hereby incorporated byreference. The tube clip can have a plate-like base adhered to theanchor pad and be located on either side of the retainer to accommodateleft or right hand mounting.

The tube clip desirably defines a channel having a generally circularcross-sectional configuration truncated to form an upper orifice. Thediameter of the channel is desirably slightly less than that of thefluid supply tube so as to ensure a secure interconnection. The channelreceives a portion of the fluid supply tube through the orifice uponapplication of gentle pressure or by pulling the tubing across andthrough the orifice of the tube clip. The clip surrounds a substantialportion of the tubing with the tubing positioned within the channel.

In use, a health care provider loops the IV supply tubing around fromthe insertion site and insert a portion of the tubing into the tubeclip. The looped section has sufficient slack to form a conventionalsafety loop. The safety loop absorbs any tension applied to the fluidsupply tube to inhibit pulling of the catheter.

The skilled artisan will also recognize the interchangeability ofvarious features from different embodiments. For instance, the angularorientation of the receiving surface illustrated in FIG. 3 can beemployed with the cradles illustrated in FIGS. 4 and 5. Thus, variousfeatures of the embodiments can be combined in order to adapt thesecurement device to a particular application.

Although this invention has been described in terms of certain preferredembodiments, other embodiments apparent to those of ordinary skill inthe art are also within the scope of this invention. Accordingly, thescope of the invention is intended to be defined only by the claims thatfollow.

1. An apparatus for securing a medical article to a patient, theapparatus comprising: an anchor, said anchor comprising an adhesivedisposed on a first surface of the anchor for contacting the skin of thepatient; a first retaining structure located on a second surface of theanchor and configured to interact with the medical article so as torestrict motion of the medical article in at least lateral andlongitudinal directions; and a second retaining structure, wherein thesecond retaining structure is configured to interact with the medicalarticle so as to restrict motion of said medical article in a transversedirection.
 2. The apparatus of claim 1, wherein the first retainingstructure comprises a post extending generally transversely away fromthe anchor, said post being configured to extend through a correspondingaperture in the medical article.
 3. The apparatus of claim 2, furthercomprising a second post, wherein said second post is configured toextend through a corresponding aperture in the medical article.
 4. Theapparatus of claim 1, further comprising a wall defining a recess inwhich a portion of the medical article can be placed, wherein the wallis configured to extend about and contact a periphery of the medicalarticle.
 5. The apparatus of claim 4, wherein the recess is generallyshaped to match a secured portion of the medical article placed therein.6. The apparatus of claim 1, wherein the second retaining structurecomprises an second adhesive layer located on the opposite side of theanchor from the first adhesive layer, said second adhesive layer beingconfigured to contact a portion of the medical article.
 7. The apparatusof claim 6, wherein the second adhesive layer is disposed upon asubstantially planar surface.
 8. The apparatus of claim 7, wherein thesecond adhesive layer is substantially cross-shaped.
 9. The apparatus ofclaim 6, further comprising a member extending transversely upward fromthe anchor, said member defining a retaining surface configured tosupport a portion of the medical article, wherein the second adhesivelayer is disposed upon said retaining surface.
 10. The apparatus ofclaim 9, wherein said retaining surface is substantially planar.
 11. Theapparatus of claim 10, wherein said retaining surface is oriented at anangle to the anchor.
 12. The apparatus of claim 9, wherein saidretaining surface is contoured to correspond with the portion of themedical article.
 13. An apparatus for securing a medical article to apatient, the apparatus comprising: a flexible anchor, said flexibleanchor comprising a first adhesive layer located on a first surface ofthe anchor, wherein said first adhesive layer is configured to contactthe skin of the patient to inhibit motion of the anchor relative to thepatient; a base member disposed on the opposite surface of said anchor,wherein said base member comprises a substantially planar portion; asecond adhesive layer disposed on a surface of said base member, saidadhesive layer configured to contact a portion of the medical article soas to inhibit movement of the medical article relative to the basemember, and a pair of guide members extending substantially transverselyupward from the base layer, said guide members being configured todirect a desired portion of the medical article towards the adhesivelayer when the medical article is secured to the apparatus.
 14. Theapparatus of claim 13, wherein the guide members are further configuredto inhibit motion of the medical article in at least a lateraldirection.
 15. The apparatus of claim 13, wherein the guide memberscomprise a post located on either lateral side of the adhesive layer,said posts being configured to interact with corresponding apertures onthe medical article.
 16. The apparatus of claim 13, wherein the guidemembers comprise a pair of deformable walls.
 17. The apparatus of claim16, wherein the walls comprise inwardly extending tangs, said wallsbeing deformable laterally outward to permit the medical article to beplaced in contact with the second adhesive layer.
 18. The apparatus ofclaim 13, further comprising a pedestal extending transversely upwardfrom said base member, said pedestal comprising a contact surface,wherein said second adhesive layer is disposed upon said contactsurface.
 19. The apparatus of claim 18, wherein said contact surface issubstantially planar and oriented at an angle to the planar portion ofsaid base member.
 20. The apparatus of claim 18, wherein said contactsurface is contoured to correspond with a shape of a portion of themedical article.